Why India's drug regulator has suspended licence for 'Pres Vu' eye drop that would 'replace reading glasses'

The Drugs Controller General of India (DCGI) has suspended regulatory approval for PresVu, the eye drop that stirred excitement with its claim to replace reading glasses, before it could even hit retail shelves.

India’s top drug regulator revoked the marketing and manufacturing approvals given to manufacturer Entod Pharmaceuticals citing “unauthorised promotion” and concerns over the “unsafe use” of the eye drops by patients.

With the October launch now off the table, PresVu now faces an uncertain future.

So, what exactly went wrong? And how has the company responded to the situation?

Let’s take a closer look.

What did PresVu claim?

Earlier in September, Mumbai-based Entod Pharmaceuticals made a bold claim, promoting PresVu as “India’s first eye drop specifically developed to reduce dependency on reading glasses” for people suffering from presbyopia.

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Presbyopia, an age-related condition, diminishes the eye’s ability to focus on nearby objects, commonly affecting those over 40. According to the company, PresVu would be ideal for individuals between the ages of 40-55.

The eyedrop’s key ingredient, pilocarpine, works by reducing the size of the pupils, making it easier to see objects up close. Entod Pharmaceuticals claimed that just one drop of PresVu could start working within 15 minutes, with the effects lasting up to six hours. They even suggested that using a second drop within 3-6 hours would prolong the effect.

Priced at Rs. 340 for a 5 ml bottle, the eye drops were set to be sold across pharmacies as a prescription drug.

However, on Tuesday, regulatory authority DCGI, who heads the Central Drugs Standard Control Organisation (CDSCO) stepped in and suspended the product approvals after the company was unable to justify some of the exaggerated claims it had made during the launch.

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Which claims came under the scanner?

The claims made by Entod Pharmaceuticals about PresVu eye drops came under scrutiny for being unapproved and potentially misleading.

According to the suspension order copy accessed by News18, the company had received approval for PresVu Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 per cent, but some of the promotional claims went beyond what was authorised.

Here’s a breakdown of the disputed claims:

Claim 1: The “first eye drops in India designed to reduce the need for reading glasses”.  

Company response: There are currently no other eye drops approved for the treatment of presbyopia in India.

DCGI response: “…you are informed that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 per cent wv has not been approved for any such claim that it is designed to reduce the need for reading glasses."

Claim 2: “This eye drop offers a non-invasive option that can enhance near vision without the need for reading glasses”.

Company response: In the clinical trial, subjects did not wear glasses to participate.

DCGI response: “In this regard, you are informed that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 per cent w/ is approved for the treatment of Presbyopia in adults and is not approved for such claim that these eye drop can enhance near vision without the need for reading glasses."

Claim 3: “Pres Vu can provide an advanced alternative that augments near vision within 15 minutes."

Company response: One doctor evaluated the drug product compared to the reading glasses.

DCGI response: “You are informed that the Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 per cent w/ is approved for the treatment of Presbyopia in adults and is not approved for such claim that PresVu can provide an advanced alternative that augments near vision within 15 minutes."

In the suspension order, the drug regulator said, “You tried to justify the claims for the product for which no approval was granted. You have not obtained any prior approval from the Central Licensing Authority to make such claims for the said product.”

Further action was taken after the Union Ministry of Health and Family Welfare took a “serious note” of the unauthorised promotion.

The ministry raised concerns about the product being marketed like an over-the-counter drug, whereas it was only approved for prescription use.

“The unauthorised promotion in the press and over social media had raised doubt about its unsafe use by patients and safety concerns for the public,” the ministry said.

How has Entod Pharma responded?

Entod Pharmaceuticals has announced its intention to challenge the CDSCO’s decision in court. Nikkhil K Masurkar, the company’s CEO, asserts that Entod has made no unethical or false presentation of facts to the media or public.

In a press release, the company said it revealed every fact to the DCGI during the valid controlled phase 3 clinical trial in 234 patients which was successful in showing efficacy and safety of these eye drops in patients of Presbyopia, following which it was given a nod.

Masurkar said, “Such eye drops with the same active ingredient and same concentration have been approved by the US FDA and marketed in the US for the last 3 years without any serious complications. FDA didn’t take any action on the company’s marketing the same in USA.”

The statement said, “We strongly desist this action against a proud Indian pharma company in the MSME sector company like Entod Pharmaceuticals which is purely research and innovation driven and attempts to bring new therapeutic options to the Indian market. As a result, we have decided to challenge this suspension in the court of law to get justice."

“Our fight will not only allow innovative medicines to be available in India but also encourage other pharmaceutical entrepreneurs and companies in the MSME sector to continue the research drive in India without facing similar obstacles,” it added.

With input from agencies